Course Description

Investigator non-compliance to the Statement of Investigator commitments has increased in many areas. One of the identified causes has been monitoring. Investigator compliance issues are great risks to product development success, but an even greater risk to sponsors is the lack of formal systems to manage compliance at research sites. With the promise of more sponsor inspections, the sponsor management of investigator noncompliance is an obligation that requires comprehensive management approaches that lead to control of investigational product, data integrity, and adequate documentation for regulatory inspection of sponsors monitoring programs and/or investigative sites. Seven steps in compliance management of research sites will be presented for the participants to assess their current practices for gaps and risks for preparing for potential regulatory inspection evaluating compliance management of research sites.

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Learning Objectives

• Categorize investigator non-compliance
• Define adequate escalation of non-compliance
• Summarize proactive investigator training related to sponsor’s response to non-compliance
• Employ seven comprehensive steps in compliance management
• Detect trending to better anticipate compliance issues

Who Should Attend

• Sponsor Senior Management
• Project Managers
• Clinical Research Associate Managers
• Clinical Research Associates
• Quality Assurance/Compliance Personnel

Instructor

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.